Sprint Quattro Secure S MRI™ SureScan™
GUDID 00643169356566
LEAD 6935M62 QUATTRO SECURE S MRI US
MEDTRONIC, INC.
Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead| Primary Device ID | 00643169356566 |
| NIH Device Record Key | 24927045-fd58-4e78-9247-36ba9f1e2bf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sprint Quattro Secure S MRI™ SureScan™ |
| Version Model Number | 6935M62 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
| Length | 62 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169356566 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P920015
FDA Product Code
| NVY | Permanent defibrillator electrodes |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-13 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [Sprint Quattro Secure S MRI™ SureScan™]
| 00643169690042 | LEAD 693565 SPRINT QUATTRO US MRI |
| 00643169690035 | LEAD 693558 SPRINT QUATTRO US MRI |
| 00643169356566 | LEAD 6935M62 QUATTRO SECURE S MRI US |
| 00643169356559 | LEAD 6935M55 QUATTRO SECURE S MRI US |
Trademark Results [Sprint Quattro Secure S MRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPRINT QUATTRO SECURE S MRI 85959274 4874807 Live/Registered |
Medtronic, Inc. 2013-06-13 |
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